Diabetes ComplicationsPhase 4NCT06396819
Collagen-povidone for Diabetic Seniors' Tenosynovitis
A Phase 4 study testing collagen-povidone solution in people with Diabetes Complications, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Diabetes affects 415 million adults globally, leading to hand issues. Povidone collagen shows promise in managing tenosynovitis. A clinical trial was conduced to compared its efficacy in adults over 60. It is shown that the intervention reduces pain, improves functionality, and grip strength with no complications. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- collagen-povidone solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2023to 1 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnostic of stenosing tenosynovitis
- Diagnostic of diabetes
- Adults aged 60 or older
Who cannot join
- Adults aged 60 or older
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico
Guadalajara, Jalisco, 44329
About this study
Official title: Topical Collagen-povidone Injection as an Alternative Treatment for Stenosing Tenosynovitis in Older Adults With Type 2 Diabetes Mellitus
Diabetes affects 415 million adults globally, leading to hand issues. Povidone collagen shows promise in managing tenosynovitis. A clinical trial was conduced to compared its efficacy in adults over 60. It is shown that the intervention reduces pain, improves functionality, and grip strength with no complications. Collagen povidone holds potential for treating diabetic hand issues.
Read the detailed description
A randomized clinical trial from January 2022 to January 2023 compared povidone collagen intervention with a placebo in adults aged 60 and above suffering from stenosing tenosynovitis. Participants were randomized into Case (collagen-povidone) and Control (physiological solution) groups. The study evaluated parameters like tenosynovitis, diabetes, pain, functionality, and grip strength.
- Conditions
- Diabetes Complications
- Being tested
- collagen-povidone solution
- Keywords
- intervention, Stenosing Tenosynovitis, Collagen-Povidone
- Medical subject headings
- Diabetes Complications, Tendon Entrapment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen-povidone solutionDrug
Also called Placebo
Application of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic intervention using povidone collagen | Experimental | Not described Receives: Drug: collagen-povidone solution |
| Therapeutic intervention using placebo | Placebo comparator | Not described Receives: Drug: collagen-povidone solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean evolution time of tenosynovitis
Tenosynovitis should decreased its progression in the experimental group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A therapeutic intervention using povidone collagen vs. placebo was carried out, and the patients were recruited after meeting the inclusion criteria and divided into two randomized groups (Case vs Control). Application of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396819
- Sponsor's protocol ID
- Collagen-Polyvidone-24
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Collagen-povidone Injection as an Alternative Treatment for Stenosing Tenosynovitis in Older Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06396819
- Acronym / sponsor ID
- Collagen-Polyvidone-24
- Conditions
- Diabetes Complications
- Keywords
- intervention, Stenosing Tenosynovitis, Collagen-Povidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes affects 415 million adults globally, leading to hand issues. Povidone collagen shows promise in managing tenosynovitis. A clinical trial was conduced to compared its efficacy in adults over 60. It is shown that the intervention reduces pain, improves functionality, and grip strength with no complications. Collagen povidone holds potential for treating diabetic hand issues.
Detailed description
A randomized clinical trial from January 2022 to January 2023 compared povidone collagen intervention with a placebo in adults aged 60 and above suffering from stenosing tenosynovitis. Participants were randomized into Case (collagen-povidone) and Control (physiological solution) groups. The study evaluated parameters like tenosynovitis, diabetes, pain, functionality, and grip strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A therapeutic intervention using povidone collagen vs. placebo was carried out, and the patients were recruited after meeting the inclusion criteria and divided into two randomized groups (Case vs Control). Application of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic intervention using povidone collagen | Experimental | Drug: collagen-povidone solution |
| Therapeutic intervention using placebo | Placebo comparator | Drug: collagen-povidone solution |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic of stenosing tenosynovitis
- Diagnostic of diabetes
- Adults aged 60 or older
Key exclusion criteria (1 listed)
- Adults aged 60 or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagen-povidone solutionAlso: PlaceboApplication of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group | Drug | Therapeutic intervention using placebo, Therapeutic intervention using povidone collagen |
Primary outcome
Mean evolution time of tenosynovitis
Time frame: 12 months
Tenosynovitis should decreased its progression in the experimental group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing collagen-povidone solution in people with Diabetes Complications, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean evolution time of tenosynovitis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.